Senior Director/Executive Director CMC

• Build and lead CMC teams dedicated to the development and optimization of protein biologics processes.
• Utilize your CMC expertise to steer the nomination of Development Candidates.
• Select and collaborate with CDMOs; craft contracts in partnership with Executive Leadership and Finance.
• Oversee the transfer and management of manufacturing processes with CDMOs, ranging from candidate nomination to process and analytical development, and advancing to early phase clinical manufacturing.
• Facilitate the transfer and support of analytical methods at external CROs/CDMOs.
• Direct analytical and stability programs at CROs to ensure the highest quality.
• Prepare and review technical documents and reports essential for regulatory submissions.
• Define and manage objectives, operating plans, production milestones, and overall goals for CDMO/CRO contracts.
• Spot opportunities to expedite manufacturing processes to ensure timely clinical starts.

Requirements

• A Doctorate in Biochemistry, Biology, Bioengineering, Immunology, or a related discipline is required.
• Minimum of 15 years of experience in the pharmaceutical and biotech sectors, with considerable management experience in the development and manufacturing of protein therapeutics.
• Experience in technology transfer to Contract Development and Manufacturing Organizations (CDMOs) for both non-Good Manufacturing Practices (non-GMP) and Good Manufacturing Practices (GMP) manufacturing, encompassing cell line development, process development, and scale-up.
• Expertise in the formulation of research strategies, operational management, and budgetary planning.
• A profound understanding of the drug development lifecycle, with experience in research and clinical environments.
• Proven ability to devise innovative solutions to achieve ambitious objectives and influence company direction.
• Familiarity with bispecific protein products is preferred.
• Skilled in the preparation of technical documentation for regulatory submissions.
• Demonstrated leadership and personnel management capabilities, accompanied by effective communication across various functions.
• Able to facilitate strategic discussions with senior management and external partners.
• Willingness to travel both nationally and internationally to oversee relationships with CDMOs.

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k, IRA)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)
• Family Leave (Maternity, Paternity)
• Short Term & Long Term Disability
• Training & Development
• Flexible on site schedule
• Wellness Resources
• Stock Option Plan